Crow-Fukase (POEMS) syndrome
Conditions
Interventions
Intervention type:DRUG
Name of intervention:FPF300
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:200
100-200
mg
Do
Sponsors
Chiba University hospital, department of neurology and clinical research center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria) (2) Patients who wish to undergo high-dose chemotherapy with autologus stem cell transplantation (3) Over 20 years old and less than 66 years old (4) Patients wihtout severe liver or renal dysfunction on the screening test (5) Patients who are capable of hospital admission at the time of startting clinical trial (6) Patients who are capable of ambulatory hospital visits evry 4 weeks. (7) Patients who have an clinicaly probrematic ECG (8) Patients with written informed consent. (9) Patients with informed consent to thalidomide education and risk management system
Exclusion criteria
Exclusion criteria: (1) Patients who have recieved thalidomide, lenalidomide, melpharan, or bortezomib within 4 weeks prior to the informed consent. (2)Patients who have recieved bevacizumab within 12 weeks prior to the informed consent. (3) Patients who have recieved systemic steroid administration (over than 10mg/day of predonisone) (4) Pateints who could worsen acutely during the clinical trial period (5) Females who are pregnant or desire childbearing. Males who desire fertility (6) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia) (7) Patients who have other malignancy (including myeloma or primary macroglobulinemia) (8) Patients with past medical history of allergy to thalidomide or dexamethasone (9) Patients with serious mental disorder (10) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent. (11) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks (12) Patients who are not appropriate to participate to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events during FPF300 administration peripheral blood stem cell harvest | — |
Secondary
| Measure | Time frame |
|---|---|
| Reducation rate of serum VEGF level (at the 24th week) Serum VEGF level Rate of complete remission achievement Rate of partial remission achievement Serum albumin level M-protein (serum, immunofixation) Motor function (muscle power/grip strength/ONLS) Motor conduction velocity/CMAP amplitude/F-wave latency (median nerve) Sensory condcution velocity/SNAP amplitude (median/sural nerve) Pleural effusion Vital capacity Body weight QOL(SF36) Rate of the patients who complete the clinical trial | — |
Countries
Japan
Contacts
Public ContactSonoko Misawa
Chiba University Graduate School of Medincine
Outcome results
None listed